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The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental toothpaste | Experimental | 0.1% isopropylmethylphenol and 1150ppm fluoride |
|
| Marketed toothpaste | Other | NaF/Silica toothpaste containing 1150ppm fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isopropylmethylphenol and Fluoride | Drug | 0.1% isopropylmethylphenol and 1150ppm fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Modified Gingival Index at 24 weeks | baseline to 24 weeks | |
| Change from baseline Bleeding Index at 24 weeks | baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Modified Gingival Index at weeks 6 & 12 | baseline to week 12 | |
| Change from baseline Bleeding Index at weeks 6 & 12 | baseline to week 12 | |
| Change from baseline Plaque Index at weeks 6, 12 & 24 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| D012822 | Silicon Dioxide |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Fluoride and Silica | Drug | NaF/Silica toothpaste containing 1150ppm fluoride |
|
| baseline to week 24 |
| Change from baseline plaque bacteria at weeks 12 & 24 | baseline to week 24 |
| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D008903 | Minerals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017655 | Silicon Compounds |